CMT-133 in Healthy Adult Participants

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 1

Age range

18 years - 50 years

Sex eligible

All sexes

Healthy volunteers

Accepted

Participants

64 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CMT-133 in healthy adult participants after single or multiple doses. It is a randomized, double-blind, placebo-controlled, SAD and MAD study, which will be conducted in Parts A and B, respectively. CMT-133 will be administered via SC injection. Placebo will consist of normal saline administered via the same route (SC) and in a manner indistinguishable from active treatment.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• Body weight ≤110 kg; male participants should be ≥50 kg and female participants should be ≥45 kg.
• Body mass index (BMI) between 18.0 kg/m2 and 33.0 kg/m2, inclusive.
• In good health as determined by the Investigator (or designee) based on medical history, physical examination, vital signs, electrocardiograms (ECGs), and laboratory assessment, except for findings specifically permitted elsewhere in the inclusion and exclusion criteria, or considered not clinically significant.
• Female participants must have negative pregnancy test result at screening and baseline (Day -1) and while enrolled in this study.
• Female participants must agree not to donate eggs (ova, oocytes) from the time of study drug administration through approximately 330 days after the last dose of study drug.
• Male participants with female partners of child-bearing potential must agree to meet one of the following contraception requirements from the time of signing the informed consent form until approximately 300 days after the last dose of study drug: vasectomy, or male condom use plus partner use of highly effective contraceptive methods.
• Male participants must agree not to donate sperm from the time of study drug administration through approximately 390 days after the last dose of study drug.

Exclusion Criteria:

• Any clinically significant abnormalities in physical examination, vital signs, and laboratory values observed during the Screening visit or Day -1.
• History and / or current presence of any clinically significant allergies to any drugs and food.
• History and / or current presence of clinically significant cardiovascular, peripheral vascular, or cardiopulmonary disease, including any history of structural heart disease, arrhythmia or conduction disorder.
• History of any illness or intervention that, in the opinion of Investigator (or designee), might confound the results of the study or pose an additional risk to the participant by their inclusion in the study.
• Current smokers or users of e-cigarettes and nicotine replacement products and those who have used more than 3 of these products per month within the last 6 months prior to Screening; or positive cotinine test at Screening or Day -1; or unable to abstain from smoking (including e-cigarettes and nicotine-containing and non-nicotine-containing vapes) within 48 hours prior to Day -1/check-in until discharge from the study site.
• Clinically significant bacterial, viral, fungal, protozoal, or parasitic infection requiring systemic treatment within 4 weeks prior to Screening or between Screening and Day 1.
• History of tuberculosis or systemic fungal infectious disease.
• Human immunodeficiency virus (HIV) infection or HIV seropositivity at Screening.
• Participation in any other clinical research study whilst enrolled in this study; or participation in any other clinical research study evaluating another investigational drug or therapy (including specific immunotherapy) within 30 days or ≥ 5 half-lives, whichever is longer, prior to Screening. Clinical research studies or therapy with biologics are not permitted within 3 months or ≥ 5 half-lives, whichever is longer, prior to Screening.
• Pregnant or breastfeeding women.
• Unable to comply with study requirements or otherwise believed, by the Investigator (or designee), to be inappropriate for study participation for any reason.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Triple masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (0)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

No locations are listed. Use the official study contact.

Study team and timeline

Lead sponsor

Clement Therapeutics, Inc.

Study start

2026-11 Estimated

Primary completion

2028-05 Estimated

Study completion

2028-05 Estimated

First posted

Nov 9, 2026 Actual

Last updated

Nov 9, 2026 Actual

Official study contacts