A Study of SHR-1314 in Healthy Subjects

NCT02934412 | Completed Phase 1

• 1 other identifier: SHR-1314-A101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo-controlled, single dose escalating, study in 5 sequential cohorts to investigate the effect of a single s.c. injection of SHR-1314 at 5 dose levels (20mg, 40mg, 80mg, 160mg, and 240mg) in healthy subjects. Each cohort will consist of 6 subjects receiving active drug and 2 subjects receiving placebo, for a total of approximately 40 subjects dosed at one study site.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events

  70 days

Secondary Outcomes (2)

• Serum concentrations of SHR01314

  70 days

• Serum anti-drug antibodies

  70 days

Study Arms (5)

SHR-1314 20mg

EXPERIMENTAL

20mg SHR-1314 or placebo is administered subcutaneously to healthy subjects

Drug: SHR-1314; Drug: placebo

SHR-1314 40mg

EXPERIMENTAL

40mg SHR-1314 or placebo is administered subcutaneously to healthy subjects

Drug: SHR-1314; Drug: placebo

SHR-1314 80mg

EXPERIMENTAL

80mg SHR-1314 or placebo is administered subcutaneously to healthy subjects

Drug: SHR-1314; Drug: placebo

SHR-1314 160mg

EXPERIMENTAL

160mg SHR-1314 or placebo is administered subcutaneously to healthy subjects

Drug: SHR-1314; Drug: placebo

SHR-1314 240mg

EXPERIMENTAL

240mg SHR-1314 or placebo is administered subcutaneously to healthy subjects

Drug: SHR-1314; Drug: placebo

Interventions

SHR-1314 DRUG

Single subcutaneous injection of SHR-1314 at 5 dose levels (20mg, 40mg, 80mg, 160mg, and 240mg) in healthy subjects.

SHR-1314 160mg; SHR-1314 20mg; SHR-1314 240mg; SHR-1314 40mg; SHR-1314 80mg

placebo DRUG

Single subcutaneous injection of placebo at 5 dose levels (20mg, 40mg, 80mg, 160mg, and 240mg) in healthy subjects.

SHR-1314 160mg; SHR-1314 20mg; SHR-1314 240mg; SHR-1314 40mg; SHR-1314 80mg

Eligibility Criteria

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

You may qualify if:

• Provide written informed consent before any study assessment is performed.
• Male or female between the ages of 18 and 55 years (inclusive) at screening,
• Good general health as defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including measurement of vital signs, 12-lead ECG, and clinical laboratory tests. (Evaluations must be considered "not clinically significant (NCS)" if outside of the reference range).
• Body Mass Index (BMI) of 18 to 30 kg/m2 (inclusive), and a total body weight ≥50 kg at screening.
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures as specified in the protocol.

You may not qualify if:

• Subjects who are investigational site staff members or subjects who are Sponsor employees directly involved in the conduct of the study.
• Use of other investigational drugs within 5 half-lives of screening, or within 30 days of screening (for small molecules), or until the expected pharmacodynamic effect has returned to baseline (for biologics), whichever is longer.
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory test at screening or Day -1.
• Females of child-bearing potential (defined as all females physiologically capable of becoming pregnant) and males who are unwilling or unable to use effective contraception during the study and until 2 months after drug administration (approximately 5 half-lives). Effective contraception is defined use of two of the following methods of contraception:
• Barrier method: Condom or Occlusive cap (diaphragm or cervical/vault caps).
• Female sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
• Male sterilization
• Use of established oral, injected or implanted hormonal methods of contraception,
• Use of an intrauterine device or intrauterine system.
• Blood donation of approximately 500 mL within 56 days prior to dosing on Day 1 and for the duration of the study.
• A positive urine drug screen at screening and Day -1.
• History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 100 mL of wine or 360 mL of beer or 45 mL of hard liquor) within 6 months of screening.
• Use of tobacco or nicotine containing products (including e-cigarettes) at any time within six months before screening and for the duration of the study.
• History of hypersensitivity to any of the study biologics, drugs or to drugs of similar chemical classes.
• History of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.

Sponsors & Collaborators

• Atridia Pty Ltd.: lead

Study Sites (1)

Atridia Pty Limited

Sydney, New South Wales, 2000, Australia

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nicholas Farinola, B.Sc,BMBS

  Royal Adelaide Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: October 17, 2016
• Study Start: August 22, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: November 14, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)