The purpose of this study is to test the safety and tolerability of HFB30132A when it is given by intravenously to healthy participants. Blood tests will be done to check how much HFB30132A is in the bloodstream and how long the body takes to eliminate it. Participation may include up to ten visits to the study center.
This is a Phase I, first time in human, randomized, double-blind, placebo-controlled, and
dose escalation study in healthy volunteers.
The study will comprise of:
1. A Screening Period of up to 30 days (Day -30 through Day -1);
2. A Treatment Period during which participants will be resident at the Observation Unit
from Day -1, 1 day before Investigational Medicinal Product (IMP) administration (on Day
1) until at least 24 hours after IMP administration, will be discharged on Day 2 after
all safety and/or pharmacokinetic (PK) evaluations have been completed, and
3. A Follow up Period lasting 180 days after the IMP dose. The study will be conducted at a
single study center in Cincinnati.
Drug: HFB30132A
Participants randomized to HFB30132A will be administered dose 1 in cohort 1. Participants in Cohort 2 and 3 will receive HFB30132A doses 2 and 3, respectively.
Other: Placebo
Participants randomized to placebo will receive the same volume of solution as participants on active treatment.
Inclusion Criteria:
- Subject is a healthy male or female subject, aged between 18 to 60 years (both
inclusive). Health is defined as no clinically relevant abnormalities identified by
Investigator's decision based on a detailed medical history, full physical
examination, including blood pressure, heart rate, respiratory rate, and body
temperature measurement, electrocardiogram (ECG) and clinical laboratory tests prior
to the study drug administration.
- Subject is confirmed as negative by SARS-CoV-2 RT-PCR testing on screening and prior
to admission to the unit.
- Subject voluntarily agrees to participate in this study and has given written informed
consent prior to undergoing any of the screening procedures.
- Willing and able to comply with all scheduled visits, treatment plan, clinical
laboratory tests, lifestyle guidelines, methods of contraception, including COVID-19
social distancing guidelines as described in Section 5.7.2 (under "Hygiene") from
signing of informed consent through end of study on Day 180.
- Female subjects of childbearing potential must not be planning a pregnancy or be
pregnant or lactating. All female subjects must have a negative result for the
pregnancy tests performed at screening and admission.
- Female subjects of childbearing potential (including perimenopausal females who have
had a menstrual period within 1 year prior to screening) must agree to use a reliable
method of contraception until study completion and for at least 4 weeks following
their final study visit on Day 180. Reliable contraception is defined as a method
which results in a low failure rate, i.e., less than 1% per year when used
consistently and correctly, such as hormonal contraception (oral, implant, injection,
ring, or patch) and intrauterine contraceptive devices (IUDs) at least 3 months prior
to Screening or a vasectomized partner. Note: Complete abstinence from sexual
intercourse is acceptable.
- Female subject is of non-childbearing potential defined as surgically sterile (i.e.
documented bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy)
or at least 12 months postmenopausal (defined with no menses without an alternative
medical cause and follicle stimulating hormone test in the post-menopausal range at
the screening visit.
- Male subjects with partners of childbearing potential must have had surgical
sterilization (vasectomy) at least 26 weeks prior to screening or use a male barrier
method of contraception (i.e. male condom with spermicide) during any sexual
intercourse, from Study Day -1 (beginning of confinement) until 3 months after the
final Follow-up Visit on Day 270. Note: complete abstinence from sexual intercourse is
acceptable.
- Male subjects must agree to abstain from sperm donation from initial study drug
administration through 3 months after the last Follow-up Visit on Day 180.
Exclusion Criteria:
- History of any illness or history or presence of clinically significant pathology
that, in the opinion of the investigator, might confound the results of the study or
pose an additional risk in administering study drug(s) to the subject or collecting
samples for analysis. This includes, but is not limited to, a history of relevant drug
or food allergies; history of clinically significant cardiovascular, pulmonary,
autoimmune, psychiatric or central nervous system disease, or of cancer with systemic
spread in remission for less than 5 years.
- Use of any medications started within 14 days (or 5 half-lives, whichever is longer)
prior to study drug administration including, prescription medications, nutritional
supplements, and over-the-counter medications except for vitamin supplements, hormonal
contraception, and recommended doses of acetaminophen, aspirin or ibuprofen
- Hospitalization for any reason within 60 days prior to the screening visit
- History of or positive human immunodeficiency virus (HIV) screen result, or positive
blood test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody
(HBcAb). Subjects with positive hepatitis C virus (HCV) antibody at the screening
visit are only eligible if they have previously completed treatment for HCV and have
confirmatory negative test for HCV RNA.
- History of drug or alcohol abuse within 1 year prior to screening, or positive test
for drugs of potential abuse at screening and admission, where alcohol abuse is
defined as regular consumption exceeding 7 drinks/ week for women, and 14 drinks/ week
for men.
- Participation (defined as receipt of dose of investigational agent) in any clinical
research study evaluating another investigational drug or therapy within 30 days or at
least 5 half-lives (whichever is longer), of the investigational drug prior to the
screening visit
- Blood donation of approximately 1 pint (500 mL) within 60 days prior to dosing, or
donation of more than 1 unit of plasma within 30 days prior to the start of study drug
dosing
- Receipt of any transfused blood products within 60 days of the screening visit.
- Any history of receiving treatment or vaccination against SARS-CoV-2
- Febrile illness within 28 days prior to the first dose of study drug, or other signs
or symptoms consistent with SARS-CoV-2 infection in the judgement of the Investigator
in the 14 days prior to the first dose of study drug.
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States
Leela Vrishabhendra, MD, Principal Investigator
Medpace, Inc.