NCT06050460

Brief Summary

In this first-in-humans dose escalation study, SA55 will be evaluated for safety, tolerability, and pharmacokinetics. The study is intended to enable future studies of SA55-injection's efficacy in preventing and treating COVID-19.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_1 covid19

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

August 26, 2023

Last Update Submit

September 20, 2023

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Incidence of participants with adverse events (AEs) and serious AEs in healthy individuals

    The incidence of adverse events (including clinical symptoms and vital signs abnormalities, laboratory examination abnormalities, 12 lead electrocardiogram abnormalities, etc.) and serious adverse events;

    6 months

Secondary Outcomes (7)

  • Time to reach maximum concentration (Tmax)

    6 months

  • Observed maximum concentration (Cmax)

    6 months

  • Elimination half life (t½)

    6 months

  • Systemic clearance (CL)

    6 months

  • Volume of distribution (Vd)

    6 months

  • +2 more secondary outcomes

Study Arms (2)

SA55 injection

EXPERIMENTAL

Cohort 1: 150mg; Cohort 2: 300mg; Cohort3: 600 mg; Cohort4: 900 mg

Drug: SA55 Injection

Placebo for SA55 injection

PLACEBO COMPARATOR

Cohort 1: 0mg; Cohort 2: 0mg; Cohort3: 0mg; Cohort4: 0mg

Other: Placebo for SA55 injection

Interventions

SA55 InjectionDRUG

Novel coronavirus broad-spectrum neutralizing antibody SA55 injection

SA55 injection
Placebo for SA55 injectionOTHER

Placebo for Novel coronavirus broad-spectrum neutralizing antibody SA55 injection

Placebo for SA55 injection

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female 18-65 on the day of enrollment;
  • Overall good health condition, with no significant abnormalities during screening and/or pre medication physical examinations;
  • Male subjects weighing ≥ 50.0kg; Female subjects with a weight of ≥ 45.0kg and a BMI between 18.0-28.0kg/m2 (including boundary values);
  • The subjects and their sexual partners did not have any family planning during the study period, voluntarily took effective contraceptive measures, and did not have plans to donate sperm or eggs; Or for surgical sterilization (female: bilateral fallopian tube ligation, bilateral ovariectomy or hysterectomy; male: vas deferens ligation or vas deferens blockage surgery);
  • Volunteer to participate in the experiment, cooperate with the visit, and sign an informed consent form before the start of the study.

You may not qualify if:

  • Individuals who are known to be allergic to the investigational drug, any component in the preparation, or other similar drugs;
  • The test results of hepatitis B B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), HIV antibody (HIV Ab) or Treponema pallidum antibody were positive;
  • Suffering from severe neurological disorders (epilepsy, seizures or convulsions) or mental illness, with a family history of mental illness, and neurological and psychiatric problems associated with various organic disorders;
  • Abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or obvious bruising or coagulation disorders diagnosed by a doctor;
  • Other uncontrolled chronic or severe disease history, including but not limited to cardiovascular disease, hematological system disease, liver and kidney disease, digestive system disease, respiratory system disease, malignant tumor, history of major organ transplantation, or any other disease or physiological condition that the researcher believes can interfere with the test results;
  • The target injection site (deltoid muscle of the upper arm) may interfere with drug administration or local reaction observation due to skin damage, inflammation, ulcers, rashes, and scars;
  • (Female subjects) who are pregnant (including those who have tested positive for pregnancy) or are breastfeeding;
  • Have received any SARS-CoV-2 neutralizing antibody injection that is already on the market or in research before screening;
  • Participated in clinical trials of other drugs or medical devices within 3 months prior to screening;
  • Individuals with a body temperature greater than 37.0 ℃ on the day of medication (Day 1);
  • weeks prior to screening for clinically significant acute or chronic disease exacerbations, or a history of surgery;
  • It is known that there is a history of SARS CoV-2 infection within 3 months (including positive detection of COVID-19 nucleic acid/antigen during enrollment and screening) or COVID-19 vaccine has been vaccinated;
  • Blood donation\>400 mL or significant blood loss\>400 mL within 3 months prior to medication; Donate plasma or platelets within one month before medication;
  • Within the first 6 months of screening, use of immunoglobulins or blood products, immune modulators such as corticosteroids and thymosin α Or blood stimulating drugs;
  • Received attenuated live vaccine within 14 days prior to screening, or received subunit or inactivated vaccine within 7 days;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Ditan Hospital Capital Medical University

Beijing, 100015, China

RECRUITING

Related Publications (1)

  • Zhou Y, Meng X, Li J, Zeng G, Wang J, Cao Y, Hu C, Jin R. Safety, tolerability, and pharmacokinetics of anti-SARS-CoV-2 monoclonal antibody SA55 injection in healthy participants. Antimicrob Agents Chemother. 2025 Aug 6;69(8):e0056825. doi: 10.1128/aac.00568-25. Epub 2025 Jul 17.

    PMID: 40673766DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ronghua Jin

    Beijing Ditan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronghua Jin

CONTACT

01084323059ronghuajin@ccmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The study will be blinded for all placebo controlled dose groups, ie, the principal investigator (PI), all clinical staff involved in the clinical study, the participants, and the study monitor will remain blinded, unless safety concerns or a regulatory requirement necessitate unblinding.
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2023

First Posted

September 22, 2023

Study Start

June 15, 2023

Primary Completion

October 30, 2023

Study Completion

December 30, 2023

Last Updated

September 22, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)