A Phase 1 Study of Single and Multiple Intravenous Doses of SM17 in Healthy Subjects

NCT05332834 | Completed Phase 1 FDA Drug

• 1 other identifier: SM17-101
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

SM17

Outcome Measures

Primary Outcomes (1)

• Part A and Part B: Number of subjects with adverse events

  To evaluate the safety and tolerability of intravenous doses of SM17 in healthy adult subjects.

  Until Follow-up (FU) Visit/Early Termination (ET) Visit (14 and 28 days post-last dose)

Secondary Outcomes (1)

• Pharmacokinetic parameters of SM17 in healthy subjects

  0-20 weeks

Other Outcomes (2)

• Pharmacokinetic parameters of SM17 in healthy subjects

  0-20 weeks

• Pharmacokinetic parameters of SM17 in healthy subjects: time to peak (Tmax)

  0-20 weeks

Study Arms (2)

Drug SM17

EXPERIMENTAL

Peripheral intravenous injection

Biological: SM17

Drug Placebo

PLACEBO COMPARATOR

Peripheral intravenous injection

Other: Placebo

Interventions

SM17 BIOLOGICAL

Peripheral intravenous injection

Drug SM17

Placebo OTHER

Peripheral intravenous injection

Drug Placebo

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 12.4.5.
• Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit.
• Is a non-smoker or ex-smoker who has stopped smoking for at least 6 months prior to the screening visit. Ex-smokers will have a history of \<10 cigarettes pack-year.
• Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs (12-lead reporting RR, PR, QRS, QT and QTcF), as deemed by the PI or designee, at the screening visit and prior to the first dosing, including the following:
• QTcF interval is ≤460 msec (males) and ≤470 msec (females) and has ECG findings considered normal or not clinically significant by the PI or designee.
• Must sign an IRB-approved informed consent form (ICF) prior to any study-specific procedures.
• Is able to comply with clinic visits and study-related procedures.

You may not qualify if:

• 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.
• History of any known primary or secondary immunodeficiency disorder.
• History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
• Positive drugs and/or alcohol results at the screening visit or prior to the first dosing. Subject who has consumed alcohol within 48 hours prior to any study visit including the screening visit, will be excluded.
• History or presence of hypersensitivity or idiosyncratic reaction to protein treatment, medications, any ingredients of SM17 or related compounds.
• Female subjects of childbearing potential.

Sponsors & Collaborators

• SinoMab BioScience Ltd: lead

Study Sites (1)

Celerion Lincoln

Lincoln, Nebraska, 68502, United States

Location

Related Publications (1)

• Xu G, Paglialunga S, Qian X, Ding R, Webster K, van Haarst A, Engel C, Hui CW, Lam LH, Li W, Wu WC, Rasmussen S, Hunt A, Leung SO. Evaluation of the safety, tolerability, pharmacokinetics and pharmacodynamics of SM17 in healthy volunteers: results from pre-clinical models and a first-in-human, randomized, double blinded clinical trial. Front Immunol. 2024 Dec 9;15:1495540. doi: 10.3389/fimmu.2024.1495540. eCollection 2024.

  PMID: 39717777 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

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

Model Details: Biological Product: SM17 monoclonal antibody or Placebo

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 18, 2022
• Study Start: June 14, 2022
• Primary Completion: September 26, 2023
• Study Completion: September 26, 2023
• Last Updated: September 27, 2024

Record last verified: 2024-02

Locations

US (1)