A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ascending, Subcutaneous, Single and Multiple Doses of SHP681 (Glucagon-like Peptide-2 [GLP-2] Analog-Fc Fusion) in Healthy Adult Participants
Condition: Healthy Volunteers
Intervention: SHP681; Placebo
Intervention description: Participants will receive SC injection of SHP681 in the abdomen.; Participants will receive SC injection of placebo matched to SHP681 in the abdomen.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to assess the safety and tolerability of single and multiple
      ascending subcutaneous (SC) doses of SHP681 in healthy adult participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to voluntarily provide written, signed, and dated informed consent to
             participate in the study.

          -  An understanding, ability, and willingness to fully comply with study procedures and
             restrictions.

          -  Age 18-50 inclusive at the time of consent. The date of signature of the informed
             consent is defined as the beginning of the screening period. This inclusion criterion
             will only be assessed at the first screening visit.

          -  Male, or non-pregnant, non-lactating female who agrees to comply with any applicable
             contraceptive requirements of the protocol or females of non-childbearing potential.

          -  Considered "healthy" by the investigator. Healthy status is defined by absence of
             evidence of any active or chronic disease or condition based on a detailed medical and
             surgical history, a complete physical examination including vital signs, 12-lead
             electrocardiogram (ECG), hematology, blood chemistry, and urinalysis.

          -  Body mass index between 18.0 kilograms per square meter (kg/m^2) and 30.0 kg/m^2
             inclusive with a body weight 50-100 kg (110-220 pounds [lbs]). This inclusion
             criterion will only be assessed at the first screening visit.

        Exclusion Criteria:

          -  History of any hematological, hepatic, respiratory, cardiovascular, renal,
             neurological or psychiatric disease, gall bladder removal, or current or recurrent
             disease that could affect the action, absorption, or disposition of the
             investigational product, or clinical or laboratory assessments.

          -  Current or relevant history of physical or psychiatric illness, any medical disorder
             that may require treatment or render the participant unlikely to fully complete the
             study, or any condition that presents undue risk from the investigational product or
             procedures.

          -  Known or suspected intolerance or hypersensitivity to the investigational product(s),
             closely-related compounds, or any of the stated ingredients.

          -  Significant illness, as judged by the investigator, within 2 weeks of the first dose
             of investigational product.

          -  Known history of alcohol or other substance abuse within the last year.

          -  Donation of blood or blood products (example [eg], plasma or platelets) within 60 days
             prior to receiving the first dose of investigational product.

          -  Within 30 days prior to the first dose of investigational product:

               1. Have used an investigational product (if elimination half-life is less than (<) 6
                  days, otherwise 5 half-lives).

               2. Have been enrolled in a clinical study.

               3. Have had any substantial changes in eating habits, as assessed by the
                  investigator.

          -  Use of dipeptidyl peptidase (DPP)-4 inhibitors within 30 days or 5 half-lives,
             whichever is greater, prior to administration of the investigational product.

          -  Confirmed systolic blood pressure greater than (>) 139 millimeters of mercury (mmHg)
             or <89mmHg, and diastolic blood pressure > 89mmHg or <49 mmHg.

          -  Twelve-lead ECG demonstrating corrected QT interval by Fredericia (QTcF) >450
             millisecond (msec) at screening. If QTcF exceeds 450 msec, the ECG should be repeated
             2 more times and the average of the 3 QTcF values should be used to determine the
             participant's eligibility.

          -  Positive screen for alcohol or illicit drugs at screening or Day -1.

          -  Male participants who consume more than 21 units of alcohol per week or 3 units per
             day. Female participants who consume more than 14 units of alcohol per week or 2 units
             per day.

             (1 alcohol unit equal to [=] 1 beer or 1 wine (5 ounce [oz] per 150 milliliter [mL])
             or 1 liquor (1.5 oz/40 mL) or 0.75 oz alcohol).

          -  Positive human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or
             hepatitis C virus (HCV) antibody screen.

          -  Use of tobacco in any form (eg, smoking or chewing) or other nicotine-containing
             products in any form (eg, gum, patch). Ex-users must report that they have stopped
             using tobacco for at least 30 days prior to receiving the first dose of
             investigational product.

          -  Routine consumption of more than 2 units of caffeine per day or participants who
             experience headaches associated with caffeine withdrawal. (1 caffeine unit is
             contained in the following items: one 6 oz (180 mL) cup of coffee, two 12 oz (360 mL)
             cans of cola, one 12 oz cup of tea, three 1 oz (85 g) chocolate bars. Decaffeinated
             coffee, tea, or cola are not considered to contain caffeine).

          -  Prior screen failure (unless Sponsor approval is given), randomization, participation,
             or enrollment in this study or prior exposure to any GLP-2 analogs.

          -  Unresected gastrointestinal (GI) polyp, known polyposis condition, or premalignant
             changes in the GI tract.

          -  Any history of malignancy in the GI tract or treatment for any other malignancy in the
             previous 5 years.

          -  Current use of any medication (including over-the-counter, herbal, or homeopathic
             preparations; with the exception of hormonal replacement therapy or hormonal
             contraceptives and occasional use of ibuprofen or acetaminophen and pre-approved
             medication for sedation or other medications required during or after the endoscopy).
             Current use is defined as use within 14 days of the first dose of investigational
             product.

          -  Findings of subclinical hepatobiliary disease, such as gallstones, on abdominal
             ultrasound at screening as determined by the Investigator in consultation with the
             Medical Monitor.