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Healthy ParticipantsPhase 1NCT03036865

Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of BOS161721 in Healthy Subjects

A Phase 1 study testing BOS161721 in people with Healthy Participants, run by Boston Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Study BOS161721-01 is a randomized, single center, double-blind, placebo-controlled trial conducted to study the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending intravenous (IV) and subcutaneous (SC) doses of BOS161721 or placebo in healthy adult male and female participants. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
BOS161721
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
61 participants
Where
1 siteUnited States
Study dates
Jan 2017to 27 Apr 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participant voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the Screening procedures
  • Participants should be between 18 and 55 years (both inclusive) of age at the time of Screening, with a body mass index (BMI) between 17.5 and 32 kilograms per meters squared (kg/m^2) (both inclusive) at the time of Screening, have a weight > 50 kg and < 120 kg at the time of Screening, and be in general good health at least 8 weeks prior to the Screening visit. Good health is defined as individuals without known disease(s) as determined by a responsible physician, based on medical evaluation, including medical history, physical examination, laboratory tests, imaging, and cardiac monitoring.
  • Women of non-childbearing potential status:
  • Hysterectomy;
  • Bilateral tubal ligation/tubal occlusion;
  • Bilateral salpingectomy;
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  • Bilateral oophorectomy;
  • Postmenopausal - defined as 12 months of spontaneous amenorrhea (In questionable cases, a blood sample will be taken with simultaneous testing of follicle-stimulating hormone (FSH) and estradiol levels, which should be consistent with menopausal range.)
  • Women of childbearing potential will be allowed to participate and have to agree to use at least 1 of the following contraception methods at all times throughout study participation in addition to either a condom with spermicide or a diaphragm/cervical cap with spermicide:
  • Non-hormonal intrauterine device (IUD; Paragard®/copper)
  • Hormonal IUD (Mirena®)
  • Nexplanon® or implantation - progesterone inserts under the skin
  • Males will either be sterile, agree to be abstinent from Day -1 through the last study visit, or agree to use 2 highly effective methods of contraception such as:
  • A male condom with spermicide;
  • A sterile sexual partner;
  • Use by female sexual partner of an IUD with spermicide; a female condom with spermicide; contraceptive sponge with spermicide; an intravaginal system; a diaphragm with spermicide; a cervical cap with spermicide; or oral, implantable, transdermal, or injectable contraceptive(s).
  • Non-smokers or people who smoke up to 5 cigarettes per day but less than 10 packs per year
  • Participants should be willing and able to comply with all study procedures. The criterion for inclusion will be reviewed and verified at Screening and admission.

Who cannot join

  • Prior clinical trial experience with monoclonal antibodies if there were clinically relevant tolerability issues with previous administration or if a washout period of 60 days or 5 half-lives (whichever is longer) has not occurred prior to the planned first day of dosing
  • History of any autoimmune disease (e.g., rheumatoid arthritis, Lupus)
  • History or current diagnosis of cancer, with the exception of non-melanoma skin cancer or cervical cancer in situ treated with apparent success with curative therapy (response duration > 5 years)
  • Asthma, currently treated with or in the opinion of the Principal Investigator likely to require additional systemic glucocorticosteroid therapy during the study, is exclusionary.
  • History of any clinically important drug or vaccine allergy or anaphylaxis
  • A cluster of differentiation 4 (CD4+) lymphocyte count < 500 cell/millimeters cubed (mm^3) at Screening
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  • Positive anti-keyhole limpet hemocyanin (KLH) antibodies at Screening
  • Previous immunization with KLH
  • Known allergy to shellfish, KLH vaccine, or hypersensitivity to proteins foreign to the body
  • Levels of Immunoglobulin G (IgG) and Immunoglobulin M (IgM) outside of reference value deemed clinically significant by the Principal Investigator at Screening
  • History or sensitivity to heparin or heparin-induced thrombocytopenia
  • Participants with cryptosporidium in the stool sample at Screening
  • Abnormal bilirubin or alanine aminotransferase (ALT) at Screening as judged by the Principal Investigator to be clinically significant
  • Positive urine drug screen at Screening or Day -1
  • History of alcohol dependence as determined by a positive alcohol serum test at Screening or Day -1 or participants who consume more than 14 (female participants) or 21 (male participants) units of alcohol a week (unit = 1 glass of wine [125 milliliters (mL)/4 ounces] = 1 measure [25 mL/1 ounce] of spirits = 284 mL [10 ounces] of beer)
  • Participants who have a positive test, or have been treated, for Hepatitis A, Hepatitis B, Hepatitis C virus, human immunodeficiency virus (HIV), cytomegalovirus (CMV) or Epstein-Barr virus (EBV). Regarding Hepatitis B, any of the following would exclude the participant from the study:
  • Participants with positive Hepatitis B Surface antigen (HBsAg);
  • Participants with Hepatitis B DNA levels > 200 copies/mL (quantified by real-time polymerase chain reaction) in case the participant is positive for Hepatitis B surface antibody (HBsAb) but negative for HBsAg;
  • Positive for Hepatitis B core antibody (HBcAb)
  • Current clinical, radiographic, or laboratory evidence of active tuberculosis (TB)
  • A history of active TB within the last 3 years before Screening, even if treated
  • Therapy for latent TB that has not been completed as per local country guidelines
  • Positive interferon gamma release assay (IGRA) for TB unless proper treatment is documented, as described above
  • Donation of blood (> 500 mL) or blood products within 2 months (56 days) prior to Day -1
  • Any medically relevant pre-existing condition that could jeopardize the safety of the participant during the trial
  • Any participant, on the judgment of the Principal Investigator, who would be considered unsuitable for the clinical trial
  • A shingles infection in the last 6 months prior to Screening
  • Live vaccination or use of steroids in the last 2 months prior to Screening
  • Use of prescription medications (except for oral contraceptive) and over-the-counter treatments, including herbal supplements such as St. John's Wart (except multivitamins), in the 2 weeks prior to Screening
  • Participants with poor dental health and/or severe foot fungal infections, as judged by the Principal Investigator

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Study site

    Baltimore, Maryland

Other trials in United States

About this study

Official title: A Double-blind, Phase 1, Single Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of BOS161721 in Healthy Subjects

Study BOS161721-01 is a randomized, single center, double-blind, placebo-controlled trial conducted to study the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending intravenous (IV) and subcutaneous (SC) doses of BOS161721 or placebo in healthy adult male and female participants.

Read the detailed description

Study BOS161721-01 will consist of 7 single ascending dose (SAD) cohorts, each with 8 participants (6 active:2 placebo), and an eighth SAD cohort with 5 participants (all active). Participants will be randomized in a 3:1 ratio (BOS161721:placebo) and will either receive a single dose of BOS161721 (1, 3, 10, 22, 30, 60, 120, or 240 milligrams [mg]) or placebo. Participants in Cohort 1 will receive the lowest dose, administered IV (1 mg), followed by Cohort 2, in which participants will receive the second lowest dose, administered SC (3 mg). BOS161721 or placebo will also be administered SC in Cohorts 3, 4, 5, 7, and 8. Participants in Cohort 6 will be administered an IV dose of 22 mg (5 active) in parallel to the 60 mg SC-dosed fifth cohort. This dose has been selected to generate a similar exposure to that following the 30 mg SC dose. The actual Cohort 6 IV dose may be adjusted upon available PK data.

Participants will be in this study for up to 56 weeks, which includes a Screening Period of up to 28 days, a single-dose treatment day (during the in-subject treatment period), and a 52-week post-treatment Follow-up Period, which is required due to the potential half-life of BOS161721.

Being tested
BOS161721, Placebo
Keywords
Healthy participants, BOS161721, Pharmacokinetics, Pharmacodynamics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BOS161721Drug

    Single dose administered IV or SC

  • PlaceboDrug

    Single dose administered IV or SC

Study groups in NCT03036865
Study groupRoleWhat they receive
Cohort 1: 1 mg, IV BOS161721ExperimentalEach participant will receive a single intravenous (IV) dose of BOS161721 1 milligram (mg).
Receives: Drug: BOS161721
Cohort 1: matching placeboPlacebo comparatorEach participant will receive matching IV placebo.
Receives: Drug: Placebo
Cohort 2: 3 mg, SC BOS161721ExperimentalEach participant will receive a single subcutaneous (SC) dose of BOS161721 3 mg.
Receives: Drug: BOS161721
Cohort 2: matching placeboPlacebo comparatorEach participant will receive matching SC placebo.
Receives: Drug: Placebo
Cohort 3: 10 mg, SC BOS161721ExperimentalEach participant will receive a single SC dose of BOS161721 10 mg.
Receives: Drug: BOS161721
Cohort 3: matching placeboPlacebo comparatorEach participant will receive matching SC placebo.
Receives: Drug: Placebo
Cohort 4: 30 mg, SC BOS161721ExperimentalEach participant will receive a single SC dose of BOS161721 30 mg.
Receives: Drug: BOS161721
Cohort 4: matching placeboPlacebo comparatorEach participant will receive matching SC placebo.
Receives: Drug: Placebo
Cohort 5: 60 mg, SC BOS161721ExperimentalEach participant will receive a single SC dose of BOS161721 60 mg.
Receives: Drug: BOS161721
Cohort 5: matching placeboPlacebo comparatorEach participant will receive matching SC placebo.
Receives: Drug: Placebo
Cohort 6: 22 mg, IV BOS161721ExperimentalEach participant will receive a single IV dose of BOS161721 22 mg.
Receives: Drug: BOS161721
Cohort 7: 120 mg, SC BOS161721ExperimentalEach participant will receive a single SC dose of BOS161721 120 mg.
Receives: Drug: BOS161721
Cohort 7: matching placeboPlacebo comparatorEach participant will receive matching SC placebo.
Receives: Drug: Placebo
Cohort 8: 240 mg, SC BOS161721ExperimentalEach participant will receive a single SC dose of BOS161721 240 mg.
Receives: Drug: BOS161721
Cohort 8: matching placeboPlacebo comparatorEach participant will receive matching SC placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with any treatment-emergent serious adverse event (TESAE)

    Measured: up to 52 weeks

  2. Number of participants with any treatment-emergent non-serious adverse event (TEAE)

    Measured: up to 52 weeks

  3. Number of participants with TESAEs of the indicated severity

    Measured: up to 52 weeks

  4. Number of participants with TEAEs of the indicated severity

    Measured: up to 52 weeks

  5. Number of participants with abnormal, clinically significant electrocardiogram findings

    Single-day dosing will occur on Day 1.

    Measured: Days -1 and 4 (Residential Period); Days 15, 30, and 90 (Follow-up Period)

  6. Number of participants with abnormal, clinically significant vital sign (blood pressure, heart rate, temperature) values

    Single-day dosing will occur on Day 1.

    Measured: Screening; Days -1, 1, 2, 4, and 7 (Residential Period); Days 15, 30, 44, 60, 90, 180, 210, 270, and 360 (Follow-up Period)

  7. Number of participants with abnormal, clinically significant hematology parameter values

    Single-day dosing will occur on Day 1.

    Measured: Screening; Days -1, 1, 2, 4, and 7 (Residential Period); Days 15, 30, 44, 60, 90, 180, 210, 270, and 360 (Follow-up Period)

  8. Number of participants with abnormal, clinically significant clinical chemistry parameter values

    Single-day dosing will occur on Day 1.

    Measured: Screening; Days -1, 1, 2, 4, and 7 (Residential Period); Days 15, 30, 44, 60, 90, 180, 210, 270, and 360 (Follow-up Period)

  9. Mean total immunoglobulin G (IgG) levels

    Single-day dosing will occur on Day 1.

    Measured: Screening; Days -1 and 4 (Residential Period); Days 15, 30, 60, 210 and 270 (Follow-up Period)

  10. Mean total immunoglobulin M (IgM) levels

    Single-day dosing will occur on Day 1.

    Measured: Screening; Days -1 and 4 (Residential Period); Days 15, 30, 60, 210 and 270 (Follow-up Period)

  11. Mean cluster of differentiation 4 (CD4+) cell count

    Single-day dosing will occur on Day 1.

    Measured: Screening; Days -1, 4, and 7 (Residential Period); Days 15, 30, 44, 60, 90, 180, 210, 270, and 360 (Follow-up Period)

  12. Number of participants with abnormal, clinically significant physical examination findings

    Single-day dosing will occur on Day 1.

    Measured: Screening; Day -1 (Residential Period)

  13. Number of participants with abnormal, clinically significant targeted physical examination findings

    Single-day dosing will occur on Day 1.

    Measured: Day 7 (Residential Period); Days 15, 44, 90, 180, 270, and 360 (Follow-up Period)

Secondary outcomes (13)

  1. Mean maximum observed concentration (Cmax) of intravenous (IV) BOS161721

    Measured: Day 1 of Cohorts 1 and 6: predose, at the end of infusion/injection (30 minutes); at 0.5, 1, 2, 4, 8, and 12 hours postdose. Postdose on Days 2, 4, 7, 15, 30, 44, 90, 180, 210, 270, and 360 for Cohorts 1 and 6.

  2. Mean Cmax of subcutaneous (SC) BOS161721

    Measured: Day 1 of Cohorts 2, 3, 4, 5, 7, and 8: predose; following subcutaneous injection on Day 1. Postdose on Days 2, 4, 7, 15, 30, 44, 90, 180, 210, 270, and 360 for Cohorts 2, 3, 4, 5, 7, and 8.

  3. Mean first time to maximum concentration (Tmax) of IV BOS161721

    Measured: Day 1 of Cohorts 1 and 6: predose, at the end of infusion/injection (30 minutes); at 0.5, 1, 2, 4, 8, and 12 hours postdose. Postdose on Days 2, 4, 7, 15, 30, 44, 90, 180, 210, 270, and 360 for Cohorts 1 and 6.

  4. Mean Tmax of SC BOS161721

    Measured: Day 1 of Cohorts 2, 3, 4, 5, 7, and 8: predose; following subcutaneous injection on Day 1. Postdose on Days 2, 4, 7, 15, 30, 44, 90, 180, 210, 270, and 360 for Cohorts 2, 3, 4, 5, 7, and 8.

  5. Mean area under the concentration-time curve (AUC) of IV BOS161721

    Measured: Day 1 of Cohorts 1 and 6: predose, at the end of infusion/injection (30 minutes); at 0.5, 1, 2, 4, 8, and 12 hours postdose. Postdose on Days 2, 4, 7, 15, 30, 44, 90, 180, 210, 270, and 360 for Cohorts 1 and 6.

  6. Mean AUC of SC BOS161721

    Measured: Day 1 of Cohorts 2, 3, 4, 5, 7, and 8: predose; following subcutaneous injection on Day 1. Postdose on Days 2, 4, 7, 15, 30, 44, 90, 180, 210, 270, and 360 for Cohorts 2, 3, 4, 5, 7, and 8.

  7. Mean terminal elimination half-life (t½) of IV BOS161721

    Measured: Day 1 of Cohorts 1 and 6: predose, at the end of infusion/injection (30 minutes); at 0.5, 1, 2, 4, 8, and 12 hours postdose. Postdose on Days 2, 4, 7, 15, 30, 44, 90, 180, 210, 270, and 360 for Cohorts 1 and 6.

  8. Mean t½ of SC BOS161721

    Measured: Day 1 of Cohorts 2, 3, 4, 5, 7, and 8: predose; following subcutaneous injection on Day 1. Postdose on Days 2, 4, 7, 15, 30, 44, 90, 180, 210, 270, and 360 for Cohorts 2, 3, 4, 5, 7, and 8.

  9. Mean systematic clearance (CL) of IV BOS161721

    Measured: Day 1 of Cohorts 1 and 6: predose, at the end of infusion/injection (30 minutes); at 0.5, 1, 2, 4, 8, and 12 hours postdose. Postdose on Days 2, 4, 7, 15, 30, 44, 90, 180, 210, 270, and 360 for Cohorts 1 and 6.

  10. Mean CL of SC BOS161721

    Measured: Day 1 of Cohorts 2, 3, 4, 5, 7, and 8: predose; following subcutaneous injection on Day 1. Postdose on Days 2, 4, 7, 15, 30, 44, 90, 180, 210, 270, and 360 for Cohorts 2, 3, 4, 5, 7, and 8.

  11. Mean volume of distribution (Vd) of IV BOS161721

    Measured: Day 1 of Cohorts 1 and 6: predose, at the end of infusion/injection (30 minutes); at 0.5, 1, 2, 4, 8, and 12 hours postdose. Postdose on Days 2, 4, 7, 15, 30, 44, 90, 180, 210, 270, and 360 for Cohorts 1 and 6.

  12. Mean Vd of SC BOS161721

    Measured: Day 1 of Cohorts 2, 3, 4, 5, 7, and 8: predose; following subcutaneous injection on Day 1. Postdose on Days 2, 4, 7, 15, 30, 44, 90, 180, 210, 270, and 360 for Cohorts 2, 3, 4, 5, 7, and 8.

  13. Number of participants with anti-drug antibodies (ADA) to BOS161721

    Measured: up to Day 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2017 (estimated)
  2. Study startJan 2017
  3. Primary completion27 Apr 2018
  4. Study completion27 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03036865
Sponsor's protocol ID
BOS161721-01
Other IDs
PXL232187
Status last verified
Nov 2020
First submitted
27 Jan 2017
Last updated
18 Nov 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Hussaini A, Mukherjee R, Berdieva DM, Glogowski C, Mountfield R, Ho PTC. A Double-Blind, Phase I, Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of BOS161721 in Healthy Subjects. Clin Transl Sci. 2020 Mar;13(2):337-344. doi: 10.1111/cts.12715. Epub 2019 Nov 29.

    PubMed 31664766

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BOS161721 in people with Healthy Participants, run by Boston Pharmaceuticals at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with any treatment-emergent serious adverse event (TESAE) (time frame: up to 52 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03036865, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.

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