Single and Multiple Dose Evaluation of QBKPN SSI In Healthy Volunteers

Qu Biologics

Status and phase: Withdrawn; Phase 1

Conditions: Healthy

Treatments: Biological: QBKPN; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02897999

QBKPN-03

Details and patient eligibility

About

The purpose of this dose-escalation study is to assess the safety and pharmacodynamics of single and multiple doses of QBKPN SSI, administered subcutaneously to healthy adult volunteers

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy, non-smoking (at least for 6 months prior to first study drug administration) males or females, 18 to 65 years of age, inclusive at the time of informed consent.
• Body mass index (BMI) that is within 18.5 - 30.0 kg/m2, inclusive.
• Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination
• Systolic blood pressure between 95-140 mmHg, inclusive, and diastolic blood pressure between 55-90 mmHg, inclusive, and heart rate between 50-100 bpm, inclusive, unless deemed otherwise by the PI/Sub-Investigator.
• QTc interval ≤ 450 milliseconds for males and females, unless deemed otherwise Not Clinically Significant by the Principal Investigator/Sub-Investigator.
• Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements.
• Agree not to have a tattoo or body piercing until the end of the study.
• Agree to practice effective methods of contraception

Exclusion criteria

• Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the PI/Sub-Investigator.
• A known history or positive test result for human immunodeficiency virus (HIV), chronic Hepatitis B surface antigen, or Hepatitis C.
• A positive test result for drugs of abuse (marijuana, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines), alcohol test and cotinine. Positive pregnancy test for female subjects.
• Known history or presence of (1) Alcohol abuse or dependence within one year prior to first study drug administration; (2) Drug abuse or dependence; (3) Known or suspected hypersensitivity to any component of the product (4) Food allergies and/or presence of any dietary restrictions; or (5) Severe allergic reactions (e.g. anaphylactic reactions, angioedema).
• Recent history (within 8 weeks prior to screening) of travel to or emigration from any country with high incidence for tuberculosis.
• A positive tuberculin skin (PPD) test result

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 10 patient groups

SAD Cohort 1

Experimental group

Description:

Single dose of 0.05 mL QBKPN or Placebo

Treatment:

Biological: QBKPN

Other: Placebo

SAD Cohort 2

Experimental group

Description:

Single dose of 0.10 mL QBKPN or Placebo

Treatment:

Biological: QBKPN

Other: Placebo

SAD Cohort 3

Experimental group

Description:

Single dose of 0.20 mL QBKPN or Placebo

Treatment:

Biological: QBKPN

Other: Placebo

SAD Cohort 4

Experimental group

Description:

Single dose of 0.40 mL QBKPN or Placebo

Treatment:

Biological: QBKPN

Other: Placebo

SAD Cohort 5

Experimental group

Description:

Single dose of 0.80 mL QBKPN or Placebo

Treatment:

Biological: QBKPN

Other: Placebo

SAD Cohort 6

Experimental group

Description:

Single dose of 1.2 mL QBKPN or Placebo

Treatment:

Biological: QBKPN

Other: Placebo

MAD Cohort 1

Experimental group

Description:

5 doses of QBKPN or Placebo administered every other day (using one of the dose from the SAD Cohort)

Treatment:

Biological: QBKPN

Other: Placebo

MAD Cohort 2

Experimental group

Description:

5 doses of QBKPN or Placebo administered every other day (using one of the dose from the SAD Cohort)

Treatment:

Biological: QBKPN

Other: Placebo

MAD Cohort 3

Experimental group

Description:

5 doses of QBKPN or Placebo administered every day (using one of the dose from the SAD Cohort)

Treatment:

Biological: QBKPN

Other: Placebo

MAD Cohort 4

Experimental group

Description:

5 doses of QBKPN or Placebo administered every day (using one of the dose from the SAD Cohort)

Treatment:

Biological: QBKPN

Other: Placebo