A Phase 1, First-in-Human, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SM17 When Administered Intravenously as a Single Ascending Dose in Healthy Subjects (Part A) and as Multiple Ascending Doses in Healthy Subjects (Part B)

SinoMab BioScience Ltd1 site in 1 country78 target enrollmentJune 14, 2022

ConditionsAsthma

InterventionsSM17 Placebo

DrugsSM17

Overview

Phase: Phase 1
Intervention: SM17
Conditions: Asthma
Sponsor: SinoMab BioScience Ltd
Enrollment: 78
Locations: 1
Primary Endpoint: Part A and Part B: Number of subjects with adverse events
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This trial is a phase 1, first-in-human, randomized, double-blind, placebo-controlled dose escalation trial following single and multiple doses intravenous administration of SM17.

It aims to evaluate the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic effect and immunogenicity of single and multiple doses of SM17 injection in healthy subjects.

Registry

clinicaltrials.gov

Start Date

June 14, 2022

End Date

October 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

SinoMab BioScience Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must fulfill all of the following inclusion criteria to be eligible for participation in the study:
•Healthy, adult, male or female\* (of non childbearing potential only), 19-55 years of age, inclusive, at the time of consent.
•\* Females of non-childbearing potential are defined as follows:
•Females who have undergone one of the following sterilization procedures at least 6 months prior to the first dosing:
•Hysteroscopic sterilization.
•Bilateral tubal ligation or bilateral salpingectomy.
•Hysterectomy.
•Bilateral oophorectomy or
•Females who are postmenopausal with amenorrhea for at least 1 year prior to the first dosing and follicle stimulating hormone (FSH) serum levels consistent with postmenopausal status at the screening visit.
•Male subjects must follow protocol specified contraception guidance as described in Section 12.4.

Exclusion Criteria

•Subjects must not be enrolled in the study if they meet any of the following criteria:
•Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
•History or evidence of a clinically significant disorder (including psychiatric), condition or disease that, in the opinion of the PI or designee would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
•History or current medical conditions, such as myocardial infarction or stroke within the 3 months prior to the screening visit, known cardiac disease, uncontrolled hypertension, and aortic or cerebral aneurysm.
•Previously hospitalized for severe acute respiratory syndrome-coronavirus 2 (SARS Cov 2) prior to the screening visit.
•Positive polymerase chain reaction test for SARS-CoV-2, either with the absence or presence of the clinical symptoms of COVID 19
•Has evidence of any active or suspected bacterial, viral, fungal, or parasitic infections within the past 6 weeks prior to the screening visit (e.g., common cold, viral syndrome, flu-like symptoms). Subject who, in the opinion of the PI or designee, has a high risk of parasitic disease is also excluded.
•Has known Type I/II diabetes.
•Was vaccinated with live (attenuated) vaccinations within 1 month prior to the first dosing.
•History of malignancy of any type, (with the exception of successfully treated in situ cervical cancer, or surgically excised non-melanomatous skin cancers) within 5 years prior to the screening visit.