A Single Ascending Dose Escalation to Investigate Safety and PK of VVZ-149 Injection in Healthy Older Male Volunteers

NCT02333318 | Completed Phase 1

• 1 other identifier: PT-VVZ149-02
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to investigate the safety, tolerability and pharmacokinetics (PK) of VVZ-149 injection after a single dose or loading/maintenance dose in healthy older male volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity and maximum tolerated dose

  Any Common Toxicity Criteria for Adverse Effects grade 3 or more adverse event , All significant toxicity judged by the investigator

  8 day

Secondary Outcomes (1)

• Safety and Tolerability as measured by Adverse event, physical examination, vital signs, 12-lead ECG, consecutive ECG, SpO2 monitoring and Clinical laboratory.

  8 day

Other Outcomes (1)

• The pharmacokinetics parameters: AUClast, AUCinf and Cmax

  [Single Dose Trial] * Blood sampling (17 times) pre-dose and 0.25, 0.5, 1, 2, 3, 4, 4.25, 4.5, 5, 5.5, 6, 7, 8, 12, 24 and 32 h post-dose * Urine collection (5 times) pre-dose and 0-6, 6-12, 12-24 and 24-32 h post-dose [Loading/maintenance Dose Trial] *

Study Arms (3)

Single Dose_VVZ-149 injection

EXPERIMENTAL

1. Cohort A (50-64 years old), Cohort B (65-84 years old) 2. For 2.5, 5mg/kg 3. 4-hr intravenous infusion of VVZ-149 injection 4. 6 subjects will be administered within each age group. Total 24 subjects will participate.

Drug: VVZ-149 injection

Loading/Maintenance_VVZ-149 injection

EXPERIMENTAL

1. Cohort A (50-64 years old) This trial is conducted only in the Cohort A one week after the single IV infusion. 2. For Loading + Maintenance dose: 0.75 mg/kg+ 0.55 mg/kg/h, 1.5 mg/kg + 1.10 mg/kg/h 3. intravenous infusion 4. 4 subjects will be randomly assigned within each dose group, respectively. Total 8 subjects will participate.

Drug: VVZ-149 injection

Loading/Maintenance_Placebo

PLACEBO COMPARATOR

1. Cohort A (50-64 years old) 2. For Loading + Maintenance dose: 0.75 mg/kg+ 0.55 mg/kg/h, 1.5 mg/kg + 1.10 mg/kg/h 3. intravenous infusion 4. 2 subjects will be randomly assigned within each dose group, respectively. Total 4 subjects will participate.

Other: Placebo

Interventions

VVZ-149 injection DRUG

Colorless, transparent liquid in water for injection

Also known as: VVZ-149 injection or water for injection

Loading/Maintenance_VVZ-149 injection; Single Dose_VVZ-149 injection

Placebo OTHER

water for injection

Also known as: VVZ-149 injection or water for injection

Loading/Maintenance_Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who voluntarily agree to participate and sign an IRB-approved informed consent form (ICF) prior to receiving any of the screening procedures
• Healthy male subjects aged between 50-84, inclusive at screening (the subjects aged 65 years or over can participate only in the single dose trial)
• Subjects with body weights between 50-90 kg, inclusive and with body mass index (BMI) between 18.0-29.9 kg/m2, inclusive
• Healthy subjects satisfying eligibility at screening (medical histories, physical examination, vital sign, electrocardiogram (ECG), hematology, clinical chemistry and urinalysis)
• Subjects who willing to use an medicinal allowed method of contraception or sterility during the study period

You may not qualify if:

• Subjects who have a presence or history of clinically significant hepatic, renal, neurologic, immunologic, pulmonary, endocrine, hematological, neoplastic, cardiovascular or psychiatric (e.g. mood disorders or obsessive-compulsive disorder) diseases (subjects with currently well-controlled conditions including hypertension, hyperlipidemia, arthritis, prostatic hypertrophy and cataracts may allow to participate at the discretion of the investigator.)
• Subjects with chronic infection or meaningful acute infection
• Subjects who have a history of clinically significant hypersensitivities or hypersensitivities to the ingredient of same family with IP and other drug (e.g. aspirin and antibiotics)
• Subjects who have a family history of chronic pain or with a first-degree relative with chronic pain
• Subjects who have a clinically significant ECG abnormalities or QTc interval \>450 ms
• Subjects who meet the following criteria at screening:
• AST or ALT level \> 3 times the upper limit of the normal range
• Calculated eGFR by MDRD equation \< 60 ml/min
• Platelets ≤ 75,000/mm3, Hemoglobin ≤ 9 g/dL, Neutrophils absolute ≤ 1000/mm3
• Subjects who show the following vital signs at the screening:
• Systolic Blood Pressure (SBP): \<92 mmHg or \>160 mmHg
• Diastolic Blood Pressure (DBP): \<50 mmHg or \>95 mmHg
• Subjects who have a history of drug abuse or a positive urine screening for drug abuse
• Subjects who have taken any prescribed or herbal medicine within one week before the first administration of the IP or any non-prescribed medicine or vitamin supplement within three days before the first administration of the IP (if all other conditions are satisfied, these subjects may be eligible for the trial as judged by the investigator)
• Subjects who have participated in any other clinical trial within two months before the first administration of the IP

Sponsors & Collaborators

• Vivozon, Inc.: lead

MeSH Terms

Interventions

Water; Injections

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jae Yong Chung, MD, PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2014
• First Posted: January 7, 2015
• Study Start: July 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 13, 2019

Record last verified: 2015-01