A Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, PK/PD Characteristics, and Efficacy of SCTB10

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

Male

Healthy volunteers

Accepted

Participants

12 Estimated

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

About the research

Phase Ia to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of SCTB10 following a single dose in healthy participants

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:

1. Provision of written informed consent prior to initiation of any study procedures.
2. Healthy male participants aged 18 to 50 years (inclusive).
3. Body mass index (BMI) between 19 and 26 kg/m² (inclusive), and body weight ≥ 50 kg.
4. Agreement by the participant and their partner to use highly effective contraception during the study period and for 6 months following the last dose of study medication.

Exclusion Criteria:

1. History of hypersensitivity or allergy to monoclonal antibodies, or a known atopic constitution.
2. History of coronary and/or peripheral atherosclerosis, or congestive heart failure.
3. Presence of high-risk factors for thrombosis.
4. Clinically significant abnormal findings during screening, as determined by the investigator.
5. Abnormal infectious disease screening results.
6. Abnormal results in urine drug screening or breath alcohol test.
7. Use of any medication or dietary supplements within 14 days prior to the first dose.
8. Participation in another clinical trial involving the use of any investigational drug or medical device within 12 weeks prior to screening.
9. Receipt of any biologic products (including antibodies or their derivatives) within 16 weeks prior to dosing (or within 5 half-lives, whichever is longer).

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 (1)

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

1 locations

Study team and timeline

Lead sponsor

Sinocelltech Ltd.

Study start

Nov 30, 2026 Estimated

Primary completion

Jun 30, 2029 Estimated

Study completion

Aug 30, 2029 Estimated

First posted

Sep 29, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.