A Phase 1, Open-Label, Single-Dose Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, GSK3810109, Administered Either Subcutaneously or Intravenously With Recombinant Human Hyaluronidase PH20 (rHuPH20) to Healthy Adults (SPAN)

  • STATUS
    Recruiting
  • End date
    May 11, 2023
  • participants needed
    8
  • sponsor
    ViiV Healthcare
Updated on 11 October 2022
Accepts healthy volunteers

Summary

An open-label, two part study to assess the safety, tolerability, and PK of VH3810109 in healthy adult participants. Participants will receive a single SC or IV dose of VH3810109 co-administered with rHuPH20 and will be followed up for 24 weeks.

Details
Condition HIV Infections
Treatment rHuPH20, VH3810109
Clinical Study IdentifierNCT05291520
SponsorViiV Healthcare
Last Modified on11 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and without history of any of the conditions listed in the exclusion criteria
Participants having body weight of ≥50 kilogram (kg) and <100 kg
Participants having a clinical laboratory profile within the normal range or must have results that do not show clinically significant abnormalities, as judged by the investigator at screening
Contraceptive use by men or women participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Participants who are female at birth are eligible to participate if at least one of the
following conditions applies
Not pregnant or breastfeeding and at least one of the following conditions applies
Is not a participant of childbearing potential (POCBP) or Is a POCBP and agree to use an
acceptable contraceptive method as described in Section 10.4 from 3 weeks prior to the
start of this study and during the study. The investigator should evaluate the
effectiveness of the contraceptive method in relationship to the first dose of study
intervention
A POCBP must have a negative highly sensitive serum pregnancy test on Day -1, prior to the
first dose of study intervention All participants in the study should be counseled on safer
sexual practices including the use and benefit/risk of effective barrier methods (e.g
male condom)
The investigator is responsible for review of medical history, menstrual history, and
recent sexual activity to decrease the risk for inclusion of a POCBP with an early
undetected pregnancy
Capable of giving written informed consent

Exclusion Criteria

Hypertension that is not well controlled
History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal
endocrine, hematological, or neurological disorders capable of significantly altering
the absorption, metabolism, or elimination of drugs; constituting a risk when taking
the study intervention or interfering with the interpretation of data
Positive human immunodeficiency virus (HIV) antibody test
Positive test result for SARS-CoV-2
Evidence of hepatitis B (HB) virus infection at screening or within 3 months prior to
first dose of study intervention Participants positive for Hepatitis B antigen (HBsAg)
are excluded. Participants negative for anti-HBs but positive for anti-HBc (negative
HBsAg status) and positive for Hepatitis B virus (HBV) DNA are excluded
Any history of a severe allergic reaction with generalized urticaria, angioedema or
anaphylaxis within the 2 years prior to enrollment that has a reasonable risk of
recurrence during the study
The participant has an underlying skin disease or disorder (i.e., infection
inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy
urticaria) or tattoos that would interfere with assessment of injection sites
History of sensitivity to any of the study medications or their components or drugs of
their class, or a history of drug or other allergy that, in the opinion of the
investigator or medical monitor, contraindicates their participation
Clinically significant multiple or severe drug allergies, intolerance to topical
corticosteroids, or severe post-treatment hypersensitivity reactions (including, but
not limited to, erythema multiforme major, linear immunoglobulin A, dermatosis, toxic
epidermal necrolysis, and exfoliative dermatitis)
Exposure to an experimental drug, human blood product, or vaccine (which does not have
emergency, conditional, or standard market authorization) within 28 days prior to the
first dose of study treatment OR plans to receive live vaccines during the study
Prior receipt of licensed or investigational Monoclonal antibody (Mab)
Receipt of any investigational study agent within 28 days prior to first dose of study
treatment
Prior exposure to VH3810109 or rHuPH20 in this or another clinical study
Where participation in the study would result in donation of blood or blood products
in excess of 500 milliliter (mL) within 56 days
Exposure to more than 4 new chemical entities within 12 months prior to the first
dosing day
ALT ≥1.5 times the upper limit of normal (ULN)
Total bilirubin ≥1.5 times the ULN (isolated total bilirubin >1.5×ULN is acceptable if
total bilirubin is fractionated and direct bilirubin <35%)
Current or chronic history of liver disease or known hepatic or biliary abnormalities
(with the exception of Gilbert's syndrome or asymptomatic gallstones)
Corrected QT interval Fridericia's formula (QTcF)>450 millisecond (msec) for males and
QTcF >470 msec for females
The participant has a tattoo or other dermatological condition overlying potential
injection sites that may interfere with interpretation of ISRs or administration of
VH3810109
Grade 4 laboratory abnormalities
Any other chronic or clinically significant medical condition that in the opinion of
investigator would jeopardize the safety or rights of the subject including (but not
limited to): diabetes mellitus type I, chronic hepatitis; OR clinically significant
forms of drug or alcohol abuse, asthma, autoimmune disease, psychiatric disorders
heart disease, or cancer
Known hypersensitivity to hyaluronidase or any of the excipients in ENHANZE™ Drug
Product (EDP)
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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