Phase 1 Clinical Study of GenSci155 Injection in Healthy Adults

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorChangchun GeneScience Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

None

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • GenSci155 Injection
  • Placebo

Treatment groups

68 Participants
are divided into 2 treatment groups