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

NCT07847697 | Not Yet Recruiting Phase 1

• 1 other identifier: SCTB10-A201
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (4)

• dose limited toxicity (DLT).

  To determine the maximum tolerated dose (MTD) and/or RP2D.

  Up to approximately 6 weeks.

• Incidence of TEAE.

  TEAE refers to 'treatment emergent adverse event'.

  Up to approximately 25 weeks.

• Incidence of TRAE.

  Incidence of TEAE related to the experimental drug.

  Up to approximately 25 weeks.

• Incidence of SAE.

  SAE refers to 'serious adverse event'.

  Up to approximately 25 weeks

Secondary Outcomes (3)

• Blood Concentrations of SCTB10

  Up to approximately 25 weeks

• Activated Partial Thromboplastin Time and Thrombin Generation Assay

  Up to approximately 25 weeks

• Incidence of anti-SCTB10 antibody (ADA) and neutralizing antibody (Nab).

  Up to approximately 25 weeks

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

Drug: Placebo

SCTB10 group

EXPERIMENTAL

Drug: SCTB10

Interventions

SCTB10 DRUG

SCTB10 will be subcutaneously administered as a single dose in healthy volunteers

SCTB10 group

Placebo DRUG

Placebo will be subcutaneously administered in Healthy Volunteers

Placebo group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of written informed consent prior to initiation of any study procedures.
• Healthy male participants aged 18 to 50 years (inclusive).
• Body mass index (BMI) between 19 and 26 kg/m² (inclusive), and body weight ≥ 50 kg.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 29, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): August 30, 2029
• Last Updated: September 29, 2026

Record last verified: 2026-09

Locations

CN (1)