A first-in-human study to test the safety and tolerability of an experimental medicine (CVTX-55832), given at different dose levels, in healthy volunteers
| ISRCTN | ISRCTN12338815 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12338815 |
| Sponsor | Covant Therapeutics Operating, Inc |
| Funder | Covant Therapeutics Operating, Inc |
- Submission date
- 26/08/2026
- Registration date
- 10/09/2026
- Last edited
- 10/09/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This study aims to test a new investigational drug, CVTX-55832, compared with a placebo at different doses, to find out if it is safe and to understand the way people process the drug. A placebo looks like a drug but has no active ingredient.
Who can participate?
Healthy men and women aged 18 to 65.
What does the study involve?
The study has two parts. In Part 1, participants receive one dose of CVTX-55832 or a placebo, with the dose level increasing between successive groups of participants. In Part 2, participants receive multiple doses of CVTX-55832 or placebo.
Participants stay at the study site for a period of continuous monitoring after dosing, then attend follow-up visits so the study team can track safety and how the body responds.
What are the possible benefits and risks?
Participants are not expected to receive any direct benefits from the study, but the information that is learned may help develop a future treatment for people with autoimmune disease. CVTX-55832 has not yet been tested in humans. This is the first trial of CVTX-55832 in humans. For this reason, the effects of this drug are not known at this time.
Where is the study run from?
New Zealand Clinical Research.
When is the study starting and how long is it expected to run for?
October 2026 to June 2027.
Who is funding the study?
Covant Therapeutics Operating, Inc.
Who is the main contact?
Kayla Malate, kayla.malate@nzcr.co.nz.
Contact information
Scientific
1111B S Governors Ave STE 48073
Dover
19904
United States of America
| Phone | +1-215-964-8700 |
|---|---|
| shannon.mullican@covanttx.com |
Public
1111B S Governors Ave STE 48073
Dover
19904
United States of America
| Phone | +1 3149547645 |
|---|---|
| brett.venker@covanttx.com |
Principal investigator
3 Ferncroft St
Grafton
1010
New Zealand
| Phone | +64-9-373-3474 ext.7038 |
|---|---|
| Rohit.Katial@nzcr.co.nz |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Placebo |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | A first-in-human, phase I, randomised, double-blind, placebo-controlled, single-centre study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of CVTX-55832 in healthy participants |
| Study objectives | Primary: To evaluate the safety and tolerability of single and multiple ascending doses of CVTX-55832 in healthy adult participants. Secondary: To determine the pharmacokinetic profile of CVTX-55832 following single and multiple ascending doses. To determine the pharmacodynamic effects (change in IgG from baseline) of single and multiple ascending doses of CVTX-55832. |
| Ethics approval(s) |
Submitted 31/08/2026, Northern Health and Disability Ethics Committees (HDEC), Ministry of Health (133 Molesworth Street, PO Box 5013, Wellington, 6011, New Zealand; -; hdecs@health.govt.nz), ref: 2026 FULL 26754 |
| Health condition(s) or problem(s) studied | Healthy volunteers |
| Intervention | Method of randomization: Participants are allocated to CVTX-55832 or matching placebo (6:2 within each cohort) using a computer-generated permuted block randomisation schedule with a predefined allocation ratio, generated and finalised before first dose. Sealed participant-specific code-break envelopes are retained at site for emergency unblinding. Part 1 (SAD): Eligible healthy adult participants will be enrolled and randomized to receive a single administration of CVTX-55832 or placebo at a ratio of 6:2. Part 1 provisionally plans for 5 sequential escalating single-dose cohorts. Escalation to the next cohort proceeds only after review of available safety, tolerability, and pharmacokinetic data. Dose levels are determined stepwise and are not fixed in advance. Participants who are randomised will be followed for up to 120 days. Part 2 (MAD): Eligible participants for Part 2 will be enrolled and randomized at a ratio of 6:2 to receive multiple doses of CVTX-55832. Successive cohorts proceed only after review of available safety, tolerability, and pharmacokinetic data. Participants who are randomised will be followed for up to 176 days. Specific dose levels, dosage form and route of administration are currently being treated as confidential development information and are therefore not disclosed. |
| Intervention type | Drug |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | CVTX-55832 |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 30/06/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 64 |
| Key inclusion criteria | 1. Healthy males and females who are aged 18 - 65 years 2. Body mass index between 18 - 32 kg/m2, with a body weight ≥50 kg and ≤100 kg at screening 3. Medically healthy, as determined by pre-study medical history, and without clinically significant abnormalities 4. Female volunteers: 4.1. Must agree not to donate ova from signing the ICF until the end of the study, AND 4.2. Must be of non-childbearing potential, OR 4.3. If of child-bearing potential, must: 4.3.1. Have a negative blood pregnancy test at the screening visit and a negative urine pregnancy test on admission to the study site on Day-1 4.3.2. Agree not to attempt to become pregnant or donate ova from signing the ICF until the end of the study 4.3.3. Agree to use a highly effective method of contraception from signing the ICF until the end of the study if not exclusively in a same-sex relationship or abstinent as a committed lifestyle 5. Male volunteers: 5.1. Must agree not to donate sperm from signing the ICF until the end of the study 5.2. If engaging in sexual intercourse with a female partner who could become pregnant, must agree to use adequate contraception from Day 1 until the end of the study 5.3. If engaging in sexual intercourse with a female partner who is not of childbearing potential or who is already pregnant, or a same-sex partner, must agree to use a condom from Day 1 until the end of the study |
| Key exclusion criteria | 1. Known hypersensitivity to the study drug or any of the study drug ingredients 2. History of anaphylaxis or other significant allergy 3. History or presence of CS cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, within the past 3 months 4. History of surgery or hospitalisation within 3 months prior to screening, or surgery planned during the study 5. Have an active malignancy or history of malignancy in the last 3 years 6. Presence of clinically relevant immunosuppression 7. A history of or positive test results for human immunodeficiency virus (HIV) or any history of hepatitis 8. History of or evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis diagnosed by a positive interferon gamma release assay 9. Administration of any systemic immunosuppressant agent within 6 months prior to initial study drug administration or longer if clinically relevant, i.e., B-cell depleting therapies |
| Date of first enrolment | 07/10/2026 |
| Date of final enrolment | 16/03/2027 |
Locations
Countries of recruitment
- New Zealand
Study participating centre
Screening HQ: 125 Grafton Road, Grafton
Satellite Site: 1B/300 Grey Street, Hamilton
Auckland
New Zealand
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
04/09/2026: Study’s existence confirmed by the Health and Disability Ethics Committees (HDEC), Ministry of Health, New Zealand. Specific dose levels, dosage form and route of administration are currently being treated as confidential development information and are therefore not disclosed.
