A Study of SGB-9768 in Adult Healthy Volunteers

NCT06501573 | Active Not Recruiting Phase 1

• 1 other identifier: SGB-9768-002
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, double-blind, placebo-controlled single ascending dose study of SGB-9768 in healthy volunteers. The purpose is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneously administered SGB-9768.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of SGB-9768

  Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs)

  169 days

Secondary Outcomes (9)

• Pharmacokinetics-Cmax

  48 hours

• Pharmacokinetics-Tmax

  48 hours

• Pharmacokinetics-AUClast

  48 hours

• Pharmacokinetics-AUCinf

  48 hours

• Pharmacokinetics-t1/2

  48 hours

Study Arms (2)

SGB-9768

EXPERIMENTAL

a single dose of SGB-9768 by subcutaneous (sc) injection

Drug: SGB-9768

Placebo

PLACEBO COMPARATOR

placebo calculated volume to match active treatment by sc injection

Other: Placebo

Interventions

SGB-9768 DRUG

SGB-9768 for sc injection

SGB-9768

Placebo OTHER

sterile normal saline (0.9% NaCl) for sc injection

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female subjects aged 18 to 55 years are included at the time of informed consent.
• Body mass index between 18 and 28 kg/m2 at screening, inclusive, at screening a weight of at least 45 kg for female and 50 kg for male.
• Physical examination, vital signs, 12-lead electrocardiogram, and laboratory tests be normal or slightly abnormal but not clinically significant according to investigator's judgement.
• Women of child-bearing potential who are not exclusively in same-sex relationships and males with partners of child-bearing potential must agree to use adequate contraception from signing the informed consent until 12 weeks after completion of the follow-up visit.
• Willing to comply with the protocol required visit schedule and visit requirements and provide written informed consent.

You may not qualify if:

• A history of or current surgical or medical condition that, in the opinion of the Investigator, may put the subject at significant risk (according to Investigator's judgment) or interfere with the subject's participation in the clinical study.
• History of or evidence of tuberculosis.
• History of recurrent or chronic infections.
• Subjects with a history of meningococcal infection, or subjects who are exposed to Neisseria meningitidis.
• History of asplenia or splenectomy.
• History of abnormalities in complement or hereditary complement deficiency.
• Received an investigational agent within 30 days or 5-half-lives (whichever is longer) before the first dose of the study drug or being in other clinical study.
• History or clinical evidence of drug abuse within 12 months before screening or positive screen for drugs of abuse.
• Used prescribed or over-the-counter medication within 14 days or 5 half-lives (whichever is longer) before the first dose of the study drug unless determined not clinically relevant by the Investigator.
• Any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject's participation in or completion of the study.

Sponsors & Collaborators

• Suzhou Sanegene Bio Inc.: lead

Study Sites (1)

Huashan hospital

Shanghai, China

Location

Study Design

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

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 15, 2024
• Study Start: August 6, 2024
• Primary Completion: May 3, 2025
• Study Completion: October 17, 2025
• Last Updated: January 22, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)