First-In-Man, Healthy Volunteer Study to Evaluate Safety on the Use of YQ23

NCT03802292 | Completed Phase 1

• 1 other identifier: NBI(CT)-YQ23-2015-001
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to test the safety, tolerability, pharmacokinetics (PK-the amount of study drug in the blood), and immunogenicity (how the study drug affects the immune system) of single dose and dose levels of an investigational drug called YQ23.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (11)

• Safety as assessed by the incidence of Treatment-emergent Adverse Events (TEAE)

  Number of TEAEs will be listed according to the severity (mild, moderate, severe) as assessed by the Investigator.

  From the time of signing the Informed Consent Form to final discharge from the study (approximately 8 weeks)

• Safety as assessed by the incidence of laboratory abnormalities, based on haematology, clinical chemistry, and urinalysis test results

  All serum biochemistry, haematology, and urinalysis data outside the clinical reference ranges will be listed by parameter and treatment.

  From the time of signing the Informed Consent Form to D8 visit (approximately 36 days)

• Safety as assessed by 12-lead electrocardiogram (ECG)

  ECG parameters such as PR, QRS, QT and QTcF in milliseconds will be recorded. Clinically significant abdominal findings will be reported as Adverse Events (AE).

  From the time of signing the Informed Consent Form to D8 visit (approximately 36 days)

• Safety as assessed by echocardiogram

  Clinically significant abnormal echocardiogram findings will be recorded as AEs.

  From the time of signing the Informed Consent Form to D2 visit (approximately 30 days)

• Safety as assessed by vital sign measurement of blood pressure

  Systolic and Diastolic blood pressure (in mmHg) which is outside the clinical reference ranges and considered as clinically significant will be reported as AE.

  From From the time of signing the Informed Consent Form to D8 visit (approximately 36 days)

• Safety as assessed by vital sign measurement of pulse rate

  Pulse rate (in beats/min) which is outside the clinical reference ranges and considered as clinically significant will be reported as AE.

  From From the time of signing the Informed Consent Form to D8 visit (approximately 36 days)

• Safety as assessed by vital sign measurement of oral body temperature

  Body temperature (in degree Celsius) which is outside the clinical reference ranges and considered as clinically significant will be reported as AE.

  From From the time of signing the Informed Consent Form to D8 visit (approximately 36 days)

• Safety as assessed by local tolerability assessment: pain

  The intravenous (IV) infusion site will be assessed for pain according to the following scale \[Grade 0=none, 1=does not interfere with activity, 2=interferes with activity or requires repeated use of non-narcotic pain medication, 3=prevent daily activity or requires repeated use of narcotic pain medication, 4=requires medical intervention greater than analgesia\]. Grade 3 or above will be recorded as AE.

  From the time before dosing to D3 post dose (3 days)

• Safety as assessed by local tolerability assessment: edema

  The intravenous (IV) infusion site will be assessed for edema according to the following scale \[Grade 0=0 to 24mm, 1=25 to 50mm and not interfere with activity, 2=51 to 100mm, or interferes with activity, 3=more than 100mm, and interferes with daily activity, 4=necrosis\]. Grade 3 or above will be recorded as AE.

  From the time before dosing to D3 post dose (3 days)

• Safety as assessed by local tolerability assessment: erythema intensity

  The intravenous (IV) infusion site will be assessed for erythema intensity according to the following scale \[Grade 0=None, 1=light pink, 2=pinkish red, 3=intense red\]. Grade 3 or above will be recorded as AE.

  From the time before dosing to D3 post dose (3 days)

• Safety as assessed by local tolerability assessment: erythema size

  The intravenous (IV) infusion site will be assessed for erythema size according to the following scale \[Grade 0=0 to 24mm, 1=25 to 50mm, 2=51 to 100mm, 3=more than 100mm, 4=necrosis or exfoliative dermatitis\]. Grade 3 or above will be recorded as AE.

  From the time before dosing to D3 post dose (3 days)

Secondary Outcomes (2)

• Pharmacokinetics of YQ23 as assessed by Area under curve (AUC) on all subjects

  From study Day 1 (dosing of study drug) until Day 4 of trial participation.

• Pharmacokinetics of YQ23 as assessed by the maximum concentration of YQ23 on all subjects

  From study Day 1 (dosing of study drug) until Day 4 of trial participation.

Study Arms (2)

Single Ascending Dose YQ23

ACTIVE COMPARATOR

Biological: YQ23

Single Dose Placebo

PLACEBO COMPARATOR

Biological: Matching Placebo

Interventions

YQ23 BIOLOGICAL

Single dose of YQ23 delivered via intravenous route. Ascending dose levels will be evaluated

Single Ascending Dose YQ23

Matching Placebo BIOLOGICAL

Single dose of the matching placebo delivered via intravenous route.

Single Dose Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males or females, of any ethnic origin, between 18 and 50 years of age, inclusive.
• Body mass index between 18.0 and 30.0 kg/m2, inclusive, and body weight between 50 and 100 kg, inclusive.
• In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital non-hemolytic hyperbilirubinemia \[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at Screening and Check in, as assessed by the Investigator (or designee).
• Females of non-childbearing potential defined as permanently sterile (ie, due to hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or postmenopausal (defined as at least 12 months postcessation of menses without an alternative medical cause and follicle stimulating hormone level ≥ 40 mIU/mL). Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed in the protocol.
• Able to comprehend and willing to sign an Informed Consent Form and to abide by the study restrictions.
• Subjects must agree to receive a bovine product.

You may not qualify if:

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance (excluding non-active hay fever), unless approved by the Investigator (or designee).
• Any abnormality in the 12-lead ECG that, in the opinion of the Investigator (or designee), increases the risk of participating in the study.
• Any clinically relevant findings on echocardiography, including left ventricular ejection fraction \< 50% at baseline.
• Supine blood pressure and supine pulse rate higher than 140/90 mmHg and 100 bpm, respectively, or lower than 90/50 mmHg and 40 bpm, respectively, at Screening or Check-in, confirmed by a repeat measurement.
• Liver function test results for aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), and/or bilirubin \> 1.5 x Upper Limit of Normal (ULN) at Screening or Check-in confirmed by repeat measurement.
• Total red blood cell count, total white blood cell count, and/or haemoglobin levels outside of the normal reference range at Screening or Check-in, confirmed by repeat measurement.
• History of alcoholism or drug/chemical abuse within 2 years prior to Check in.
• Alcohol consumption of \> 21 units per week for males and \> 14 units for females.
• Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at Screening or Check in.
• Positive hepatitis panel and/or positive human immunodeficiency virus test.
• Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to dosing.
• Use or intend to use any prescription medications/products other than hormone replacement therapy (HRT), oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to dosing, unless deemed acceptable by the Investigator (or designee).
• Use or intend to use slow release medications/products considered to still be active within 14 days prior to dosing, unless deemed acceptable by the Investigator (or designee).
• Use or intend to use any non-prescription medications/products (with the exception of vitamins/mineral supplements) and phytotherapeutic/herbal/plant derived preparations within 7 days prior to dosing, unless deemed acceptable by the Investigator (or designee).

Sponsors & Collaborators

• New Beta Innovation Limited: lead

Study Sites (1)

Covance CRU Limited

Leeds, United Kingdom

Location

Study Officials

• Billy Lau, PhD

  New Beta Innovation Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind, placebo-controlled
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation study to determine the safe dose level.

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 14, 2019
• Study Start: January 16, 2019
• Primary Completion: September 20, 2020
• Study Completion: November 20, 2020
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)