Phase 1 Clinical Study of GenSci155 Injection in Healthy Adults

NCT07638800 | Not Yet Recruiting Phase 1

• 1 other identifier: GenSci155-101
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, single-center, randomized, double-blind, placebo-controlled, single and multiple intravenous ascending dose clinical study to evaluate the safety, tolerability, PK, immunogenicity, and biomarker characteristics of GenSci155 after a single or multiple intravenous injection in healthy Chinese adult trial participants.

Conditions

Healthy Adult Trial Participants

Keywords

Healthy Volunteers; GenSci155

Outcome Measures

Primary Outcomes (2)

• Part1：Incidence and severity of treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs) and other safety measures

  From dosing on Day 1 up to 22 days post dose

• Part2：Incidence and severity of treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs) and other safety measures

  From dosing on Day 1 up to 31 days post dose

Secondary Outcomes (16)

• Part1:Area under the concentration-time curve (AUC0-t, AUC0-∞,AUC0-τ)of GenSci155

  From dosing on Day 1 up to 22 days post dose

• Part1:maximum concentration (Cmax)

  From dosing on Day 1 up to 22 days post dose

• Part1:time to maximum concentration (Tmax)

  From dosing on Day 1 up to 22 days post dose

• Part1:terminal elimination half-life (t1/2)

  From dosing on Day 1 up to 22 days post dose

• Part1:clearance (CL)

  From dosing on Day 1 up to 22 days post dose

Other Outcomes (1)

• Serum insulin growth factor binding protein-3 (IGFBP-3) and insulin growth factor binding protein-2 (IGFBP-2), and their changes from baseline

  From dosing on Day 1 up to 22 or 31 days post dose

Study Arms (2)

GenSci155 Injection

EXPERIMENTAL

Drug: GenSci155 Injection

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

GenSci155 Injection DRUG

Part 1 consists of a total of 6 dose cohorts，Part 2 consists of a total of 3 dose cohorts

GenSci155 Injection

Placebo DRUG

Part 1 consists of a total of 6 dose cohorts，Part 2 consists of a total of 3 dose cohorts

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult male or female trial participants, aged between 18 and 60 years (inclusive) Male body weight ≥ 50 kg and female body weight ≥ 45 kg; body mass index (BMI) between 19 and 28 kg/m² (inclusive) at screening 3.In good general condition as determined by medical history, physical examination, vital signs, ECG, laboratory tests, infectious diseases screening and urine drug screening with no clinically significant abnormalities as judged by the investigator .
• Female trial participants must have a negative pregnancy test results at screening and baseline.
• Male and female trial participants of childbearing potential must agree to use non-pharmacological contraception from screening until 3 months after the last dose. From the time of signing the ICF until 3 months after the last dose, they must have no plans for conception, sperm donation, egg donation, or egg cryopreservation. Female trial participants must have had no unprotected sexual intercourse within 14 days prior to screening.
• Trial participants must voluntarily sign the ICF, be able to understand and comply with the requirements of this trial protocol, and complete scheduled follow-up visits in a timely manner.

You may not qualify if:

• History of hypersensitivity to IGF-1 agents or their ingredients; or a history of allergic diathesis or a history of allergic diseases.
• History or current presence of hypoglycemia, or recurrent hypoglycemic episodes.
• Severe trauma or major surgical procedure within 12 months prior to screening that, in the investigator's judgment, may affect the safety of the trial participants or the interpretation of the study results, or planning to undergo any surgery during the trial period.
• Blood loss or donation exceeding 400 mL within 3 months prior to screening.
• Poor peripheral venous access; or physical condition intolerant to sampling.
• Presence of significant active systemic or local infection within 4 weeks prior to screening.
• Presence of tattoo, sunburn, scar or any other factors at screening that may interfere with the assessment of the injection site at the intended injection area.
• History or current presence of any clinically significant, poorly controlled chronic disease, organ dysfunction, or malignancy that, in the investigator's judgment, may affect participant safety or study conduct.
• Clinically significant abnormalities in chest x-ray \[P-A\] at screening.
• A positive result at screening for hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), treponema pallidum particle agglutination assay (AntiTP ), or hepatitis B virus (HBV) infection
• Females who are breastfeeding during the screening period. 12.12-Lead ECG at screening showing any of the following: QTcF interval \> 450 ms; or heart rate \> 100 beats per minute; or any other clinically significant abnormality as determined by the investigator.
• Any of the following laboratory abnormalities at screening:
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) \> upper limit of normal (ULN);
• Total bilirubin \> ULN and considered clinically significant by the investigator.
• Abnormal international normalized ratio (INR) or activated partial thromboplastin time (aPTT) judged to be clinically significant by the investigator.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location

Central Study Contacts

Qingjiang Ni

CONTACT

+86 17712631723; niqingjiang@genscigroup.com

Study Design

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

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): July 28, 2026
• Primary Completion (Estimated): April 16, 2027
• Study Completion (Estimated): July 28, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-05

Locations

CN (1)