A Study of SGB-9768 in Adult Healthy Volunteers

A Phase 1, Randomized, Double-blind, Placebo-controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered SGB-9768 in Healthy Volunteers

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: SGB-9768; Other: Placebo

Detailed Description

It is a phase 1, randomized, double-blind, placebo-controlled single ascending dose study of SGB-9768. The primary objective is to evaluate the safety, tolerability of SGB-9768 when administered subcutaneously as a single dose to healthy volunteers. The secondary objective is to characterize the pharmacokinetics and pharmacodynamics of subcutaneously administered SGB-9768 in healthy volunteers.

• Study Type: Interventional
• Enrollment (Estimated): 37
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Huashan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; placebo calculated volume to match active treatment by sc injection	Other: Placebo; sterile normal saline (0.9% NaCl) for sc injection
Experimental: SGB-9768; a single dose of SGB-9768 by subcutaneous (sc) injection	Drug: SGB-9768; SGB-9768 for sc injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability of SGB-9768	Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs)	169 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics-Cmax	Maximum Observed Plasma Concentration (Cmax)	48 hours
Pharmacokinetics-Tmax	Time at which the maximum plasma concentration (Cmax) occurs	48 hours
Pharmacokinetics-AUClast	Area under the plasma concentration-time curve from dosing (time zero) to the time of the last measured concentration	48 hours
Pharmacokinetics-AUCinf	Area Under the Plasma Concentration Versus Time Curve from Zero Extrapolated to Infinity (AUCinf)	48 hours
Pharmacokinetics-t1/2	Terminal Elimination Half-Life (t1/2)	48 hours
Pharmacokinetics-CL/F	Total Body Clearance	48 hours
Pharmacokinetics-Vz/F	Volume of Distribution (Vz/F)	48 hours
Pharmacodynamics-C3	Change From Baseline in Complement 3 (C3)	169 days
Pharmacodynamics-complement acitvity	Change From Baseline in Complement Activity	169 days

Collaborators and Investigators

• Sponsor: Suzhou Sanegene Bio Inc.
• Investigators: Study Director: Jing Zhang, PhD, Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2024
• Primary Completion (Estimated): May 3, 2025
• Study Completion (Estimated): October 17, 2025

Study Registration Dates

• First Submitted: July 9, 2024
• First Submitted That Met QC Criteria: July 9, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 19, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SGB-9768-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No