A Study of SSS68 Following a Single Subcutaneous Administration in Healthy Adult Participants

NCT07606976 | Not Yet Recruiting Phase 1

• 1 other identifier: SSS68-101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo-controlled, single ascending dose phase I clinical study to evaluate the safety, tolerability, PK, PD and immunogenicity of SSS68 in healthy adult participants following a single subcutaneous administration.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Overall Summary of Treatment Emergent Adverse Events

  The number of adverse events (AEs), serious adverse events (SAEs), and drug related adverse events following administration of SSS68.

  Baseline to day 113

Secondary Outcomes (8)

• Maximum Observed Serum Concentration (Cmax)

  0, 2, 6, and 12 hours post-dose, Day 2, 3, 4, 6, 8, 15, 22, 29, 43, 57, 85, and 113

• Time to Reach Maximum Observed Serum Concentration (Tmax)

  0, 2, 6, and 12 hours post-dose, Day 2, 3, 4, 6, 8, 15, 22, 29, 43, 57, 85, and 113

• Terminal half-life (t1/2)

  0, 2, 6, and 12 hours post-dose, Day 2, 3, 4, 6, 8, 15, 22, 29, 43, 57, 85, and 113

• Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-t])

  0, 2, 6, and 12 hours post-dose, Day 2, 3, 4, 6, 8, 15, 22, 29, 43, 57, 85, and 113

• Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-inf])

  0, 2, 6, and 12 hours post-dose, Day 2, 3, 4, 6, 8, 15, 22, 29, 43, 57, 85, and 113

Study Arms (2)

SSS68

EXPERIMENTAL

SSS68 at doses ranging from 2 mg up to 1200 mg

Drug: SSS68

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

SSS68 DRUG

A single dose of SSS68 will be administered SC on Day 1.

SSS68

Placebo DRUG

A single dose of placebo will be administered SC on Day 1.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to understand and comply with protocol requirements, voluntarily participate in the trial and sign a written informed consent form (ICF).
• Male or female participants aged 18-45 years (inclusive) when signing the ICF.
• Male participants with body weight ≥ 50 kg, and female participants with body weight ≥ 45 kg.
• Participants whose vital signs, physical examination results, laboratory test results, 12-lead electrocardiogram (ECG) and other test results are normal, or abnormal without clinical significance as determined by the investigator.
• IgG/IgM/IgA \> upper limit of normal value at the screening Visit.
• Female participants with childbearing potential and male participants (and their female partners) must agree to take highly effective contraceptive measures and have no plan of childbearing, sperm donation, or egg donation from screening through at least 6 months after the dose of study drug.

You may not qualify if:

• History of severe allergy, or with a history of allergy to the investigational drug, any of its components, or related excipients.
• With any clinically significant diseases (including but not limited to gastrointestinal, hepatic, renal, neurological, hematological, endocrine, tumor, pulmonary, immunological, psychiatric, or cardiovascular diseases) prior to the screening visit.
• Had any confirmed or suspected immunosuppressive or immune-deficient condition, including but not limited to history of opportunistic infections, asplenia, or primary immunodeficiency.
• History of recurrent or chronic infections, or any infection requiring hospitalization or intravenous antiviral/antibiotic treatment within 6 months before dosing.
• Participants with positive test results for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibody, anti-human immunodeficiency virus (HIV) antibody.
• Participants who have undergone major surgery within 6 months before dosing, or plan to undergo major surgery during the study.
• Participants who have received any marketed or investigational biological agent within 5 half-lives or 12 weeks (whichever is longer) before dosing.
• Participants who have used any prescription drugs, over-the-counter medications, vitamin supplements, or herbal products within 4 weeks or 5 half-lives (whichever is longer) before dosing.
• Participants who smoke more than 5 cigarettes per day within 3 months prior to screening.
• History of significant alcohol abuse or regular use of alcohol within 6 months prior to the screening visit.
• History of significant drug abuse, or any use of soft drugs within 3 months prior to screening, or any use of hard drugs within 1 year prior to screening, or positive result for urine drug screen test at screening.
• Participants who have been vaccinated with live or live-attenuated vaccines within 30 days before dosing, or plan to receive vaccination during the study.
• Participation in another interventional clinical trial within 3 months prior to screening.
• Participants who have donated blood (≥ 400 mL) or lost a lot of blood (≥ 400 mL) within 3 months before screening.
• QTcF ≥450 ms at the screening visit.

Sponsors & Collaborators

• Shenyang Sunshine Pharmaceutical Co., LTD.: lead

Study Sites (1)

Huashan Hospital of Fudan University

Shanghai, 200000, China

Location

Study Design

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

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)